Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML
Market
0.0%
Details
- Resolved Date
- 5/14/25
- Study Completion
- 9/1/26
- Company
- Ryvu Therapeutics SA
- Ticker
- RVU.WA
- Type
- Trial Status
- Active Not Recruiting
- Trial Size
- 94
- Volume
- $0
- NCT
- NCT06268574
- Drug Description
- The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients.
Resolution Evidence
- Outcome
- NO
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Sponsor’s May 14, 2025 RIVER-52 update is trial-specific and explicitly negative: no CRs were observed, predefined efficacy criteria were not met, the study did not advance to Part 2, and enrollment was suspended. A second public filing repeats the same framing.
Sources
Sponsorryvu.com5/14/25
Ryvu Therapeutics to Present Clinical and Preclinical Data on RVU120 at the European Hematology Association Congress 2025 in June
For RIVER-52, 39 patients received RVU120; no CRs were observed. Ryvu states predefined efficacy criteria were not met, the trial did not advance to Part 2, and enrollment was suspended.
View source
Web Searchfinancialreports.eu6/12/25
Report Content
Public filing on poster PF548 says that despite some blast reductions, no durable CRs were observed in RIVER-52 and enrollment was suspended.
View source
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